← FDA ENFORCEMENT
D-0252-2025Class II

Safecor Health, LLC

Recalling firm
Safecor Health, LLC
Product type
Drug
Status
Ongoing
Report date
2025-03-12
Distribution
Nationwide in the USA
Firm state
OH
Product quantity
1535 Oral Syringes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Product description

Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by: Safecor, Columbus, OH 43204. NDC: a) 71399748005, b) 39328055750, c) 69618007059.

Code / lot info

Lot #s: a) 24250093, Exp 03/07/2025; 24321592, Exp 04/04/2025; 24280320, Exp 03/27/2025; b) 24371268, Exp 04/19/2025; c) 24400519, Exp 04/07/2025; 24500768, Exp 06/24/2025; 25040972, Exp 07/25/2025.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.